摘要
【目的】评价桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)的有效性和安全性。【方法】240例乳腺增生病(瘀血阻络证)患者采用随机、双盲、阳性药平行对照、多中心临床试验设计方法分为试验组和对照组2组。试验组口服桂枝茯苓胶囊,5粒/次(含桂枝茯苓模拟剂胶囊2粒),每天3次;对照组口服乳癖消胶囊,5粒/次,每天3次。两组疗程均为3个月。观察两组临床疗效和主要症状体征积分的变化情况,并作安全性评价。【结果】两组治疗后总有效率试验组为84.07%,对照组为71.43%,两组比较差异有显著性意义(P<0.05),说明试验组疗效优于对照组。治疗3个月后两组中医主症积分下降比较,试验组下降值大于对照组(P<0.05)。治疗期间,两组均未出现明显不良反应。【结论】桂枝茯苓胶囊治疗乳腺增生病(瘀血阻络证)有良好的疗效,而且具有较高的安全性。
Objective To evaluate the clinical efficacy and safety of Guizhi Fuling Capsules （GFC） for hyperplasia of mammary glands with blood-stasis blocking collaterals. Methods A randomized double-blind positive-controlled parallel multi-center clinical trial was carried out in 240 patients with mammary gland hyperplasia. The patients were randomized into two groups： GFC group received oral use of GFC, 5 capsules （including 2 capsules of GFC simulator） each day, tid, and the control group received oral use of Rupixiao Capsules, 5 capsules, tid. The two groups received the corresponding treatment for 3 continuous months. After treatment, the therapeutic effect and the changes of main symptom score were observed. Meanwhile, the safety was also evaluated. Results The total effective rate was 84.07% in GFC group and 71.43% in the control group （P 〈 0.05）. The decrease of main symptom score in GFC group was superior to that in the control group （P 〈 0. 05 ）. No obvious adverse reaction was found during treatment in the two groups. Conclusion Guizhi Fuling Capsules is effective and safe for the treatment of hyperplasia of mammary glands with blood-stasis blocking collaterals.
出处
《广州中医药大学学报》
CAS
2009年第2期103-107,共5页
Journal of Guangzhou University of Traditional Chinese Medicine
基金
国家食品药品监督管理局新药临床观察项目(编号:2004ZL00331)
关键词
桂枝茯苓胶囊/治疗应用
乳腺增生病/中药疗法
瘀血阻络证
临床试验
Ⅱ期
GUIZHI FULING CAPSULES/therapeutic use
HYPERPLASIA OF MAMMARY GLANDS/TCD therapy
BLOOD-STASIS BLOCKING COLLATERALS
CLINICAL TRIAL, PHASE Ⅱ
